Neurocrine Biosciences, a San Diego-based medicine company, won Food and Drug Administration approval on Monday for a drug that makes a prominent Parkinson's disease treatment last longer. Patients in the United States, though, wouldn't have access to the drug for at least another couple months, as Neurocrine intends to hold off any launch because of coronavirus-related concerns.
CEO Kevin Gorman said that while his company's drug could be a useful addition to neurologists' toolkit, he doesn't think it's an appropriate time to be pitching a new product to them. He noted how the novel coronavirus and the disease it causes, called COVID-19, have caused many doctors, nurses and staff members at neurology offices to turn their attention to hospitals and caring for sick patients there.
"The last thing we want to do is to bother them; we do not want to take away from what they're doing there," Gorman told BioPharma Dive. "You need to let these offices, these physicians have a chance to come back to somewhat normalcy."
Neurocrine will therefore not launch its drug, which would be sold under the brand name Ongentys, until at least the second half of the year. Gorman said his company will provide an update on the rollout sometime around June.
Ongentys has been approved in Europe since mid-2016. It was developed and then marketed by BIAL Pharmaceuticals, which sold U.S. rights to Neurocrine in early 2017. The FDA's approval was expected by analysts and arrived on schedule with a previously set decision deadline of April 26.
Though Ongentys won't be available immediately following its stateside approval, Gorman said Neurocrine has still been ironing out the details of its expected launch. On pricing, he said the drug will come in lower than "specialty tier" medicines for Parkinson's, which he says cross a threshold of $670 per month.
Gorman also expects Neurocrine will have to put time and resources into educating U.S. neurologists about Ongentys. Having in hand the positive clinical data that got the drug greenlit in Europe, Neurocrine didn't have to conduct another pivotal study before filing for approval in the U.S. While that alleviates the research burden, it also means few, if any, U.S. neurologists are familiar with using Ongentys in their Parkinson's patients.
"This is an unusual situation," Gorman said. "Usually you have 50, 60, 70 clinical sites in the United States, with physicians who have all had hands-on experience."
One potential boost for Ongentys, however, is that Neurocrine's roughly 300-person sales team has already established a network of neurologists and psychiatrists through marketing another of the company's drugs, Ingrezza.
Ingrezza gained U.S. approval in 2017 to treat a different neurological movement disorder called tardive dyskinesia. Gorman notes that the doctors who prescribe this drug also treat a significant number of Parkinson's patients in the U.S., so adding Ongentys to the Neurocrine's list of offerings makes sense strategically.
Ongentys would also further diversify Neurocrine beyond Ingrezza, which accounts for almost all of the biotech's revenue. Sales of the drug have jumped each year since its approval, and, according to analysts, are likely to surpass the billion-dollar mark this year.
While analysts don't see Ongentys having the same success as Ingrezza — SVB Leerink, for instance, forecasts $250 million to $300 million in peak sales — Gorman contends the drug moves Neurocrine a step closer to being a leader in neuroscience and, more specifically, movement disorder treatments.
"It rounds us out, it continues our mission," he said. "If you want to focus on movement disorders, you have to be involved and you have to be bringing something special to the Parkinson's market."
Ongentys is meant to prolong the effects of levodopa, the standard-of-care drug for treating Parkinson's. For many patients, continued use of levodopa over years can lead to the drug's effects diminishing and the lengthening of "off periods," in which Parkinson's symptoms get worse.
Ongentys works by inhibiting an enzyme that helps to break down levodopa. Other Parkinson's drugs have acted on this enzyme but, according to Gorman, their effects weren't substantial enough for neurologists to adopt them.